Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

An LLNA study was conducted with MPG, propoxylated, according to OECD 429. Female CBA/Ca mice (twenty/group) received 0.5%, 5%, or 50% (v/v) test substance diluted using 4:1 acetone:olive oil (AOO). Lymph node stimulation indices of less than three (3) were measured for all the test groups relative to AOO vehicle mice. The test substance was considered to be a non-sensitizer under the conditions of the test.

Tetrapropylene Glycol, a major component of PPG, has been tested for dermal sensitization (Buehler teste with induction and challenge phases) in male Guinea pigs (Dow, 1996). Although the tests were not conducted according to a guideline or GLPs, adequate information was available to determine the tests and resulting data are reliable. A range-finding test was conducted in 4 Guinea pigs to determine the highest non-irritating concentration of test material. Following 6-h administration of 0.4 ml of test material (as 100, 75, 50, 25, or 10% aqueous solution), the skin was evaluated for signs of irritation. Neither erythema nor edema were observed at up to 100% test material. Therefore the additional tests were conducted with neat material. The definitive dermal sensitization test, with 10 Guinea pigs per treatment, had two phases: induction and challenge phases, and included positive (DCNB and DER-331) and negative controls (distilled water). The left side clipped skin sites of 10 male Guinea pigs were fitted with Hilltop Chambers and treated with test material, DCNB, DER-331, or water for 6 h. The following day, the treated sites were evaluated for erythema and edema. For 3 consecutive weeks, this treatment was repeated at weekly intervals (induction phase). Following a 2-week interval after the final induction treatment, the right side sites, clipped free of hair, were treated with test material, DCNB, DER-331, or water (challenge phase). In addition, naïve animals were clipped and treated similarly: 4 with Tetrapropylene Glycol, 5 with DCNB, and 5 with DER-331 to serve as challenge controls. At 24-h and 48-h post-challenge treatment, all the challenge sites were depilated and evaluated for sensitization response and the challenge control sites for irritation. No mortalities occurred and all animals appeared in good health; there was no evidence of irritation at the treated sites. For DCNB, by 48-h post-challenge, 10 out of 10 animals were graded aspositive for sensitization response, while none of the DCNB-treated challenge controls were positive for irritation. For DER-331, by 48-h post-challenge, 8 out of 10 animals were graded as positive for sensitization response, while none of the DER-331-treated challenge controls were positive for irritation. Tetrapropylene Glycol-treated animals did not demonstrate a positive response at 24 h or 48 h post-challenge, neither the induction/challenge animals nor the challenge control animals.

Based on the results, Tetrapropylene Glycol is considered as non-sensitizing.


Migrated from Short description of key information:
MPG, propoxylated is a non-sensitizer using the mouse LLNA (OECD 429)

Based on the skin irritation results for both Tetrapropylene Glycol and Tetrapropylene Glycol Crude (Tripropylene Glycol Bottoms) classification is not warranted in accordance with Directive 67/548/EEC and EU Classification, Labelling, and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. Based on eye irritation results for Tetrapropylene Glycol and Tetrapropylene Glycol Crude (Tripropylene Glycol Bottoms), instillation of neat test material was slightly (or moderately) irritating, however all clinical signs were completely resolved by 7 days post-instillation. Given the complete resolution by 72 h or 7 days, and the minimal eye effects noted, the classification of Tetrapropylene Glycol Crude (Tripropylene Glycol Bottoms) for eye irritation is not warranted in accordance to Directive 67/548/EEC and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No.1272/2008.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

The result of the testing of MPG, propoxylated according to the LLNA procedure does not warrant classification in the EU.

Based on the skin sensitization test results for Tetrapropylene Glycol classification is not warranted in accordance with Directive 67/548/EEC and EU Classification, Labelling, and Packaging of Substances and Mixtures (CLP) Regulation (EC)No. 1272/2008.